Comparative evaluation of the efficacy and safety of two doses of terbinafine (500 and 1000 mg day−1) in the treatment of cutaneous or lymphocutaneous sporotrichosis

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Abstract
The aim of this study was to evaluate the safety and efficacy of oral terbinafine (500 and 1000 mg day−1) in the treatment of cutaneous or lymphocutaneous sporotrichosis. A culture for Sporothrix schenckii was required for inclusion into this multicentre, randomized, double‐blind, parallel‐group study. Patients received either 250 mg b.i.d. or 500 mg b.i.d. oral terbinafine for up to a maximum of 24 weeks and were assessed up to 24 weeks post‐treatment. The main efficacy outcome measure was cure, defined as no lesion and absence of adenopathy at the end of follow‐up. Adverse events (AEs), laboratory tests, vital signs and ophthalmological examinations were also assessed. Sixty‐three patients (14–85 years of age) were treated with 500 mg day−1 (n = 28) or 1000 mg day−1 terbinafine (n = 35). The majority of patients were cured after 12–24 weeks of treatment, and the response was dose‐dependent throughout the study and at the end of follow‐up. The cure rate was significantly higher in patients treated with 1000 mg day−1 terbinafine compared with those treated with 500 mg day−1 terbinafine (87% vs. 52%, respectively; P = 0.004). There were no cases of relapse after 24 weeks of follow‐up in the 1000 mg day−1 terbinafine group, compared with six relapses in the terbinafine 500 mg day−1 group. Terbinafine was well tolerated and the frequency of drug‐related AEs was slightly higher in the 1000 mg treatment group. Both doses of terbinafine were well‐tolerated and effective for the treatment of sporotrichosis. The 1000 mg day−1 terbinafine dose was more efficacious than 500 mg day−1 in the treatment of cutaneous or lymphocutaneous sporotrichosis.